FDA COMPLIANCE SOLUTIONS FROM QRS SINCE 1994 Assessment of current: Policies and practices. Procedures and work instructions. Quality records. Development of: Process diagram from design to service of the medical device(s). Quality Policy and Quality Manual to comply with the CDRH/FDA and ISO 13485 Processes that comply with Quality System Regulation (QSR), Current Good Manufacturing Practice (CGMP), requirements and ISO 13485 Quality System standards. Standard operating procedures (SOPs) and work instructions (WIs) that comply with the QSR and ISO 13485 and to assure control of the quality, safety and effectiveness of the medical device(s).      Home | CEO Profile | Philosophy | Contact Us      Educate | Implement | Attain | Maintain | Audit | Improve CONTACT QUALITY AND REGULATORY SERVICES, INC. Tel: 925-787-2421 Email: © Copyright 1998-2011. All Rights Reserved. Quality and Regulatory Services Inc.